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510(k) K904167

PATHODX HERPES TYPING by Diagnostic Products Corp. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1990
Date Received
September 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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